Recall Z-1187-2013— Masimo Corporation
Class II · Terminated
Class II FDA medical device recall by Masimo Corporation, initiated 2013-03-13, terminated 2015-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).. Reason: Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button..
- Recalling firm
- Masimo Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-13
- Terminated
- 2015-06-10
- Firm location
- Irvine, CA, United States
Product description
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Reason for recall
Masimo has identified a very small number (0.02%) of Rad-8 devices with 20-pin patient cable connector that, when moved, can power off without the operator pressing the power button.
Data sourced from openFDA. This site is unofficial and independent of the FDA.